Midweek update

Rx coverage

Midweek update

David Ermer–ACA, CDC, COVID treatment, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, SDOH, U.S. Healthcare–
Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From the Omicron and siblings front —

The Wall Street Journal reports

The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.

The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.

Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.

The American Hospital Administration informs us

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.

Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”

Also, from the SDOH front, MedPage Today informs us

Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.

After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.

The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *

The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).

From the monkeypox front, the Department of Health and Human Services announced

an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.

Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone.  * * *

The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.

The American Hospital Association adds

CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported. 

From the Dobbs case front

  • CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
  • HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”

In general, the guidance does two things:

1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and

2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.

According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *

The guidance on the HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/phi-reproductive-health/index.html.

The guidance on Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.

From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.

From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.

OPM Director Ahuja Celebrates Her First Year

David Ermer–COVID-19, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

U.S. Office of Personnel Management Director Kiran Ahuja celebrated her first year in office today. Here are links to an OPM press release and a Govexec account of Director Ahuja’s press conference.

The press release identifies her “major accomplishments with respect to the FEHB Program as

  • Providing health benefits that are responsive to employee needs 
  • All Federal Employee Health Benefits (FEHB) carriers provide telehealth services ensuring access to health providers during the pandemic and on an ongoing basis going forward. In a 2021 survey, 43% of FEHB enrollees report using telehealth benefits and use was greatest among those with mental health or behavioral health concerns. 
  • In accordance with EO 14035, which directed OPM to promote equitable healthcare coverage and services for enrolled LGBTQ+ employees and their covered family members through the FEHB Program, OPM prioritized and strongly encouraged FEHB Carriers to provide gender-affirming care benefits consistent with standards published by recognized medical experts. 

From the Omicron and siblings front

The Wall Street Journal reports

  • Advisers to the Centers for Disease Control and Prevention (ACIP) backed use of Moderna Inc.’s Covid-19 vaccine in children ages 6 to 17 years.
  • Children in the age group already have access to Covid-19 vaccines made by Pfizer Inc. and its partner BioNTech SE. The advisers recommended on Thursday that Moderna’s shot should also be made available to that age range, in a pair of 15-0 votes. 
  • The advisers’ endorsement follows the Food and Drug Administration’s authorization of the shots last week. It is one of the last steps before the Moderna shot would be more broadly available in doctors’ offices, pharmacies and vaccine clinics.

Other news reports indicate that CDC Director Walensky is expected to endorse this recommendation late Thursday or Friday.

MedPage Today informs us

A fourth dose, or second booster, of Pfizer/BioNTech’s COVID-19 vaccine (Comirnaty) protected seniors living in long-term care from the most severe outcomes during the Omicron wave, despite showing a more limited effect against infection, according to prospective data from Israel.

Among over 40,000 residents, effectiveness of a fourth dose (versus a third given at least 4 months prior) was 64% and 67% against hospitalizations for either mild/moderate or severe illness, respectively, and 72% against COVID-19-related deaths, reported Khitam Muhsen, PhD, of Tel Aviv University in Israel.

From the conference front, Fierce Healthcare offers the following articles on this week’s AHIP conference:

  • SDOH — “As the healthcare industry grapples with health inequities and disparities across the country, health insurers are well-positioned to lead the charge, experts said Wednesday.”
  • Biosimilars — “[I]t is important to note that while the competition generated by these new launches can help lower payer costs—depending on pricing and available discounts—biosimilars may not necessarily be the lowest cost option in all therapeutic categories.”
  • Behavioral health — “As the team at Cigna’s Evernorth builds its strategy around behavioral health, it’s focusing on a key throughline: simplicity.”

From the Rx coverage front —

  • The Senate Commerce Committee announced clearing for Senate floor consideration the Committee leadership’s PBM transparency bill (S 4293). The vote in favor of floor consideration was 19-9. Fierce Healthcare offers an article on the Committee’s action.
  • STAT News reports on a bipartisan Senate proposal to control insulin prices by locking in current manufacturer profits. “David Mitchell, founder of Patients for Affordable Drugs, a patient advocacy group that doesn’t accept funds from the pharmaceutical industry, called the bill “disappointing,” and said it would just shift costs to patients in other ways. ‘It’s pharma’s preferred solution to drug pricing,’ Mitchell said.”
  • STAT News also tells us that “In response to rising prices for medicines, public and private payers increasingly rely on assessments of cost-effectiveness to justify coverage. But a new examination finds that such studies sponsored by drug companies were often biased in favor of setting higher prices for their medicines.” The study was published in the BMJ.
  • The FDA released an “Action Plan for Rare Neurodegenerative Diseases, Including ALS “(also known as Lou Gehrig’s Disease).

In other vaccine news, AHIP informs us that

ACIP additionally voted [today[ to recommend adults aged 65 and older preferentially receive any one of the following higher dose or adjuvanted influenza vaccines: quadrivalent high-dose inactivated influenza vaccine (HD-IIV4), quadrivalent recombinant influenza vaccine (RIV4), or quadrivalent adjuvanted inactivated influenza vaccine (aIIV4); however there is no preference between these three vaccines.

The Committee also recommended that pneumococcal vaccine PCV15 may be used as an option to PCV13 for children aged  under 19 years according to currently recommended PCV13 dosing and schedule. ACIP voted that Priorix (GSK) be used, as an option, to prevent measles, mumps, and rubella, in accordance with currently recommended schedules and off-label uses

MedPage Today reports good vaccination news

Overall rates of human papillomavirus (HPV) vaccination among adolescents increased by nearly 20% over a 5-year period, according to survey data.

Among teens ages 13 to 17, overall HPV vaccine coverage increased from 56.1% in 2015 to 75.4% in 2020, and rates for those completing the full vaccine series jumped from 40.3% to 59.3%, respectively, reported Peng-jun Lu, MD, PhD, of the CDC in Atlanta, and colleagues

“CDC’s latest data show that HPV vaccination coverage among adolescents is increasing, which is important to prevent HPV infections that can lead to several cancers in both females and males,” Lu told MedPage Today.

The authors also noted that a doctor’s recommendation was correlated with greater willingness to receive the vaccine. Of those who were advised to get vaccinated, 80.7% received vaccination compared with 51.7% who were given no such advice. These findings mirrored another study, which found that provider recommendations boosted HPV vaccination rates among kids ages 11 to 12.

Well-child visits were also associated with higher rates of vaccination. Among kids ages 11 to 12, 80.3% who had a visit were vaccinated compared with 64.8% who did not have a visit.

From the nicotine front, the New York Times reports

The Food and Drug Administration on Thursday ordered Juul to stop selling e-cigarettes on the U.S. market, a profoundly damaging blow to a once-popular company whose brand was blamed for the teenage vaping crisis. The order affects all of Juul’s products on the U.S. market, the overwhelming source of the company’s sales. 

Juul is considering its legal options.

Midweek Update

David Ermer–COVID-19, COVID-19 vaccine, Employee Wellness Programs, Rx coverage, U.S. Healthcare, Uncategorized–

From the Omicron and siblings front —

The Centers for Disease Control’s Advisory Committee on Immunization Practice meets Thursday to vote on recommending the Moderna Covid vaccine for younger folks aged 6 through 17. This drug would be an alternative Pfizer’s Covid vaccine for that age group. Assuming the ACIP votes in favor of the Moderna vaccine, then CDC Director must approve their recommendation for the health plan coverage with no cost-sharing mandate to kick in.

Medical Economics informs us

Electronic messages and postcards with primary care physicians’ (PCP) names got Black and Latino patients in the door for their COVID-19 vaccines.

Although the effects were “relatively modest,” if applied on a larger scale, an additional 238,000 Black and Latino older adults may have been vaccinated across the United States, according to a new study.

Kaiser Permanente Northern California’s Division of Research examined the effectiveness of standard and culturally tailored electronic messages and mailings from patients’ own PCPs encouraging COVID-19 vaccines from March 29 to May 20, 2021. The results were published in an original investigation, “Effect of Electronic and Mail Outreach from Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial,” in the journal JAMA Network Open.

The study involved 8,287 patients aged 65 years and older, around the California Central Valley, Fresno, South Sacramento and San Jose, divided into three groups.

This study again illustrates the value of health plans teaming with primary care providers.

From the nicotine front, the Wall Street Journal devined from the federal government’s Spring 2022 regulatory agenda, posted Tuesday, that

The Biden administration is moving forward on a plan to mandate the elimination of nearly all nicotine in cigarettes, a policy that would upend the $95 billion U.S. cigarette industry and, health officials say, prompt millions of people to quit smoking.

The plan, unveiled Tuesday as part of the administration’s agenda of regulatory actions, likely wouldn’t take effect for several years. The Food and Drug Administration plans to publish a proposed rule in May 2023, though the agency cautioned that date could change. Then the agency would invite public comments before publishing a final rule. Tobacco companies could then sue, which could further delay the policy’s implementation.

Also the Journal reports

The Food and Drug Administration is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market, according to people familiar with the matter.

The FDA could announce its decision as early as this week, the people said. The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.

Uncertainty has clouded Juul since it landed in the FDA’s sights four years ago, when its fruity flavors and hip marketing were blamed for fueling a surge of underage vaping. The company since then has been trying to regain the trust of regulators and the public. It limited its marketing and in 2019 stopped selling sweet and fruity flavors.

The company’s legal actions likely are in development now.

From the Rx coverage front —

Fierce Healthcare calls to our attention expert opinions rendered on better controlling prescription drug costs at an AHIP conference. The experts agreed that all of the stakeholders need to be at the negotiating table.

Scott Gottlieb, M.D., former Food and Drug Administration commissioner, on a panel at AHIP’s 2022 conference * * * said the challenge for regulators looking to address drug prices is the fact that a one-size-fits-all solution will not work in this market. He said instead that policymakers should consider pharmaceuticals in three buckets: drugs that are in an active market with significant rebate activity; drugs that currently monopolize the market but will lose that monopoly in the near future; and drugs that are likely to monopolize a market in the long term.

“I think we need to think about the market as those three segments and think about different policy solutions for each of them,” [and attention should be focused on the third category] Gottlieb said.

The FEHBlog agrees with the experts about the importance of engaging all of the stakeholders. There are no bad guys here at least in the FEHBlog’s view.

From the preventive services front, Medscape reports

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the United States Preventive Services Task Force (USPSTF) concludes.

However, there are two vitamins — vitamin E and beta-carotene — that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos, it notes.

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer.

The statement is published in the June 21 issue of JAMA, along with an evidence report, editorial, and patient page.

Medscape adds that this USPSTF decision aligns with a 2014 recommendation on the same topic.

From the lab test coverage front, Fierce Healthcare reports

Optum is launching a new health plan solution that aims to reduce unnecessary testing and ensure that patients are receiving the screenings that are best for them.

The laboratory benefit management tool will assist insurers in aligning lab tests with clinical guidance and will automate large parts of lab benefit administration, Optum said in an announcement provided first to Fierce Healthcare.

The company estimates that insurers could save between $12 to $36 per member per year, or about $3 billion.

Tests that lack clinical indications can lead to unneeded sample collection form patients as well as a higher risk of false positive results, which can compound unnecessary healthcare costs. There is a dearth of industry standards and efficacy data around lab tests, making it common for results to be misinterpreted or tests to be misused.

Fierce Healthcare adds that Optum is selling this tool to all health plans.

From the U.S. healthcare front, U.S. News and World Report offers 2022 rankings on the healthiest counties in the U.S. The FEHBlog recently moved from Montgomery County Maryland to Hays County Texas. Both counties score about 55 out of 100 in the rankings.

Happy First Day of Summer 2022

David Ermer–AHRQ, CDC, Congress, COVID-19, Electronic health records, Rx coverage, SCOTUS, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

From Capitol Hill, the Hill reports

The Senate voted 64 to 34 Tuesday evening to advance an 80-page gun safety bill to strengthen background check requirements for gun buyers under 21, provide funding to states to administer red flag laws and to provide billions of dollars in new federal funding for mental health services.  * * *

Senate Majority Leader Schumer (D-N.Y.) said a successful initial procedural vote would set the bill up to pass by the end of the week.  

Last week, a House Appropriations subcommittee approved the Fiscal Year 2023 Financial Services and General Government Appropriations bill, which funds OPM and the FEHB Program. The accompanying bill summary points out

  • Office of Personnel Management (OPM) – The bill includes $448 million, an increase of $75 million above the FY 2022 enacted level, for OPM to manage and provide guidance on Federal human resources and administer Federal retirement and health benefit programs.
  • Fosters equality for women and men: Eliminates provisions preventing the FEHBP from covering abortion services.

The House Appropriations Committee will mark up this bill at a meeting scheduled for Friday, June 24.

The U.S. Supreme Court today issued a 7-2 decision holding that the Medicare Secondary Payer law does not permit healthcare providers to make disparate impact claims against health plans. This decision protects ERISA and FEHB Program plans against costly litigation. Fierce Healthcare and Health Payer Intelligence also report on the decision.

From the Omnicron and siblings front —

MedPage Today informs us

Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original Omicron strain of SARS-CoV-2.

Now, BA.4 and BA.5 are here, and they’re starting to make up a larger proportion of U.S. cases.

So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?

Probably not, infectious disease experts say.

“It’s expected that there’s probably not much cross-protection between them,” Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.

The American Hospital Association tells us

More than 1 million prescriptions for the COVID-19 antiviral pills Lagevrio and Paxlovid were dispensed between late December 2021 and May 2022, but dispensing rates were lowest in the most socially and economically disadvantaged communities, according to a study released today by the Centers for Disease Control and Prevention. In a separate study of electronic health records from Kaiser Permanente Southern California over the period, fewer than 1% of patients aged 12 and older who received Paxlovid to treat mild-to-moderate COVID-19 had a COVID-19-related hospitalization or emergency department visit in the next five to 15 days. CDC said the studies “highlight the importance of ensuring access to oral antiviral medicine in treating COVID-19, a key strategy in preventing hospitalization and death.”

Speaking of hospitals, Beckers Hospital Review reports

Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * Healthgrades has recognized 399 hospitals as recipients of its 2022 Outstanding Patient Experience Award, the organization said June 21. This represents the top 15 percent of hospitals in the U.S. for patient experience.  * * * View the full list of recipients here. 

From the Rx coverage front —

  • The Food and Drug Administration released one of its news roundups today.
  • Per Stat News, a group of researchers writing in the Annals of Internal Pharmacy used Mark Cuban’s online pharmacy pricing to puncture Medicare Part D’s pricing on generic drugs.
  • Per Fierce Healthcare, CVS Health is expanding its Project Health program to Richmond, Virginia and Las Vegas. “The healthcare giant announced Tuesday that it will hold 72 events dedicated to seniors and children this year. It is also adding four new mobile units in 2022.”
  • Per Healthcare Dive, Walgreens “has partnered with managed care company Buckeye Health Plan in Ohio to open new Health Corner locations in five of the state’s northeast neighborhoods this summer. * * * About 2.3 million patients will have access to Health Corner services across 60 locations in Ohio, California and New Jersey by the summer’s end, Walgreens said on Tuesday. By the end of this year, Walgreens expects to increase the number of Health Corners from 55 to about 100, including the new Ohio locations.”

From the interoperability and telehealth fronts

  • Epic, the largest purveyor of electronic health record systems in the U.S., announced “its plan to join a new health information exchange framework to improve health data interoperability across the country. The Trusted Exchange Framework and Common Agreement (TEFCA) will bring information networks together to help ensure that all people benefit from complete, longitudinal health records wherever they receive care. In the future, TEFCA will expand to support use cases beyond clinical care, such as public health.” That’s a big boost for TEFCA, which will serve as the backbone for the nation’s EHR systems.
  • AHRQ offers research on telehealth for women’s preventive healthcare services.

Finally, STAT News reports

President Biden will soon nominate Arati Prabhakar, a physicist and former DARPA director, to serve as his next top science adviser, the White House announced on Tuesday.

If confirmed by the Senate, Prabhakar would replace the genomics researcher Eric Lander, who resigned as the head of the White House science office in February amid a workplace-bullying scandal.

The new post would be Prabhakar’s third tour as head of a federal science office. She ran DARPA, the high-stakes military research agency, from 2012 to early 2017, and served as director of the National Institute of Standards and Technology in the 1990s.

Friday Stats and More

David Ermer–CDC, COVID-19, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s weekly chart of new Covid cases from the 27th week of 2021 through the 24th week of 2022:

While the CDC did not publish its weekly Covid statistical review this week, the FEHBlog can tell you that the daily new Covid hospitalization average is 4,321 for the week ended June 15, 2022. That average is 4.7% higher than the previous week.

Here’s the FEHBlog’s weekly chart of new Covid deaths for the same period as new cases:

New cases and deaths are both stable. MedPage Today adds

About 4.5% of people who became infected with SARS-CoV-2 when Omicron was the dominant strain experienced long COVID symptoms, compared with 10.8% who became infected during the Delta period, reported Claire Steves, PhD, of King’s College London in England, and co-authors.

Overall odds of long COVID were about 20% to 50% less during the Omicron era — defined as December 2021 to February 2022 in this study — depending on age and time since vaccination, the researchers wrote in a letter to The Lancet.

For more information, Science discusses clues to long Covid.

Here’s the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020, when the Covid vaccination era began and the current 24th week of 2022.

Over 100,000 people aged 12 and older have received at least one booster.

The Wall Street Journal adds.

Vaccine advisers to the Centers for Disease Control and Prevention discussed Friday the merits of Covid-19 shots now authorized for children as young as 6 months. * * *

The committee is scheduled to discuss further the case for recommending giving the Pfizer-BioNTech and Moderna shots to young children, and then vote on the matter Saturday.

The Biden administration has said the shots could be made available as soon as Monday, should regulators give their assent.

The federal government has begun shipping millions of doses to doctor’s offices, children’s hospitals and pharmacies, President Biden said after the FDA’s authorizations.

From the Rx coverage front, STAT News and Medical Economics update us on the federal government’s investigation of prescription benefit managers. Notably, STAT News reports

Amid intensifying scrutiny of pharmacy benefit managers, a group of House Republicans is urging the U.S. Government Accountability Office [via a June 17 letter] to investigate the role these controversial middlemen play in the opaque pharmaceutical pricing system.

From the Federal Trade Commission front, Healthcare Dive tells us that the FTC has obtained several victories over the past week in its legal challenges to hospital system mergers in New Jersey, Rhode Island, and Utah.

From the No Surprises Act front, reginfo.gov informs us that on June 15, the Office of Information and Regulatory Affairs received for review the NSA regulators’ final rule on the independent dispute resolution process. OIRA review is the last step before the rule is published in the Federal Register. The healthcare provider associations mounted a successful legal challenge to the interim final rule’s treatment of the qualifying payment amount as a rebuttable presumption at the arbitration stage.

From the HIPAA standard transactions front, a Health and Human Services workgroup has issued guidance on how payers can help providers associate electronic explanations of benefits with electronic payments.

From the U.S. healthcare front, Kaiser Health News and a WTW study delve into the widespread related problems of medical debt and deferred care. On the bright side, the National Institutes of Health reports that flexible work schedules and paid sick leave improves employee access to healthcare.

Thursday Miscellany

David Ermer–Congress, COVID-19, Federal employment benefits, NIH, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Roll Call reports

The Senate on Thursday took a major step toward broadening America’s commitment to take care of sick veterans, passing a bill to offer new health care and tax-free disability benefits to as many as 3.5 million veterans on an 84-14 vote.

Under the legislation written by Veterans’ Affairs Chairman Jon Tester, D-Mont., and ranking member Jerry Moran, R-Kan., the Department of Veterans Affairs would consider a veteran with any of 23 conditions, ranging from brain cancer to hypertension, who was deployed to a combat zone during the wars in Iraq or in Afghanistan automatically eligible for care at government cost, based on the presumption that exposure to toxic chemicals in the war zone caused the ailments.

The House must now pass the revised bill before President Joe Biden can sign it, which seems likely. The legislation largely mirrors, and slightly expands on, a House bill by Veterans’ Affairs Chairman Mark Takano, D-Calif., that passed 256-174 in March. Biden issued a statement at the time saying he supported the measure.

Under current law, veterans who believe toxic exposure during their service caused them to develop a disease can have trouble proving it, even when the linkage is known. So it’s likely that many veterans are denied care and disability benefits they deserve, advocates say. The new law, at a projected cost of $278.5 billion over 10 years, shifts the calculus, meaning the government will now pay for the care of veterans whose sickness is tied to their service, as well as others whose ailments might not be.

Because the federal government employs many veterans, this bill will reduce benefits costs for the FEHB Program once it becomes law.

From the Omicron and siblings front, the Wall Street Journal informs us

Many people are embarking on a summer of vacations, concerts and weddings put off during the height of the pandemic. Covid-19 is still finding ways to disrupt some of those plans.

Covid-19 isn’t causing acute illness and death on the scale it once did, thanks in part to protection built up by vaccines and prior infections.  * * *

The U.S. is logging some 100,000 known cases a day, and many more are being detected via at-home tests health departments don’t track. This is a stark difference from a year ago, when U.S. cases sank below 12,000 a day, the lowest level since the first surge, as vaccinations rose and many hoped the virus was in retreat.

The era of 12,000 cases a day was over when Delta and then Omicron arrived and will remain around until Omicron departs.

From the Rx coverage front —

STAT News tells us

In a notable move, the Federal Trade Commission put drugmakers and pharmacy benefit managers on notice that the agency will “ramp up enforcement” of any “illegal bribes and rebate schemes” that make it harder for patients to access lower-cost medicines.

The new policy statement noted the FTC plans to scrutinize rebates and assorted fees for signs that these payments are violating antitrust and consumer protection laws. As part of that effort, the agency expects to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may raise prescription drug prices.

“Today’s action should put the entire prescription drug industry on notice: when we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” said FTC Chair Lina Khan in a statement. “Protecting Americans from unlawful business practices that are raising drug prices is a top priority for the Commission.”

While the end of Omicron is not in the offing, the end of prescription drug rebates appears to be getting closer. However, the federal government should not put the kibosh on rebates unless the drug manufacturers agree to maintain the economic equities by offering price reductions equivalent to the rebates.

In other FTC news, BioPharma Dive reports

Drugmaker acquisitions of all sizes could receive closer scrutiny in the future if the Federal Trade Commission follows the advice of experts who spoke at a two-day agency meeting on market concentration and anticompetitive conduct.

The experts, mostly economists and other antitrust regulators, warned that some drugmakers have gained unfair market power due to the breadth of their product portfolios, allowing them to negotiate for preferred or even exclusive status on insurers’ coverage lists and thereby squeeze out competitors.

Taken together with the FTC’s plans to investigate the practices of pharmacy benefit managers, the meeting signals the Biden administration may take a tougher line on monopolistic practices in an effort to spark competition and target drug pricing.

From the Food and Drug Administration front, BioPharma Dive notes that

An experimental and closely followed drug for Alzheimer’s disease has failed a key clinical study, dealing yet another blow to the prevailing theory on how to treat a neurodegenerative illness that affects millions of people.

The drug’s developer, Roche, along with Banner Alzheimer’s Institute, the Phoenix-based organization helping lead the study, announced the negative results Thursday. After years following a family believed to be genetically predisposed to the disease, researchers found no significant difference in cognition or the ability to store and retrieve new memories between participants who received the drug and those who got placebo.

The failure is an upset not only to Roche, which hopes to follow its rival Biogen in getting an Alzheimer’s therapy approved for market, but also to the wider Alzheimer’s research field. For years, a protein called beta amyloid has been at the center of efforts to treat the disease. But every drug designed to block this protein, including Biogen’s, has faced setbacks. Roche’s announcement may therefore add to concerns that this protein isn’t the best research target.

In other drug research news, Walgreens announced “the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. Walgreen’s flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.”

In U.S healthcare news, the American Medical Association completed its annual meeting. The AMA offers highlights from the session here.

Also, the Commonwealth Fund released its 2022 Scorecard on State Health System Performance.

Hawaii and Massachusetts top the 2022 State Scorecard rankings, based on overall performance across 56 measures of health care access and quality, service use and cost, health disparities, and health outcomes during the COVID-19 pandemic in 2020. The lowest-performing states were Mississippi, Oklahoma, and West Virginia.

The National Institutes of Health disclosed

From 2000-2019 overall life expectancy in the United States increased by 2.3 years, but the increase was not consistent among racial and ethnic groups and by geographic area. In addition, most of these gains were prior to 2010. This is according to a new study funded by the National Institutes of Health that examined trends in life expectancy at the county level. The study was led by researchers at the Institute for Health Metrics and Evaluation at the University of Washington’s School of Medicine, Seattle, in collaboration with researchers from NIH and published on June 16th in The Lancet.

MedCity News reports “Online healthcare marketplace Sesame closed a $27 million Series B funding round on Tuesday, bringing its total funding to $75 million. David Goldhill, CEO of the New York City-based startup, said the company is ‘an Expedia for medical care’ because patients can buy the care they want directly online, without the middleman of an insurance company.”

From the federal employee benefits front, Govexec delves into the impact of cost of living adjustments on federal employee retirement benefits.

Tuesday’s Tidbits

David Ermer–COVID treatment, COVID-19, COVID-19 vaccine, Rx coverage, Telehealth, Uncategorized–
Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, MedPage Today reports

A committee of independent vaccine experts recommended that the FDA grant an emergency use authorization (EUA) for the two-dose Moderna COVID-19 vaccine for kids ages 6 to 17 years.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 22-0, agreeing unanimously that the benefits of vaccination outweigh the risks in two age groups: kids ages 6 to 11 years and teens ages 12 to 17. They recommended two 50-mcg doses for the younger kids and two 100-mcg doses for teens.

The Wall Street Journal adds

The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older. * * * An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.

Medpage Today also informs us

Only a very small number of high-risk patients with COVID-19 experienced “rebound symptoms” after being treated with nirmatrelvir/ritonavir (Paxlovid), a retrospective study found.

Among nearly 500 patients, 93% of whom were fully vaccinated, two patients were hospitalized due to symptoms that were not directly related to “rebounding” within a month and required care in the intensive care unit (ICU), and four experienced rebound symptoms at a median of 9 days (interquartile range [IQR] 7-14.5), reported Nischal Ranganath, MD, PhD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.

All rebound symptoms were resolved with symptom-directed treatment, and no deaths were reported in any patients after 30 days following their initial COVID-19 diagnosis, the group noted in Clinical Infectious Diseases.

“We found that rebound phenomenon was uncommon in this group of patients,” said co-author Aditya Shah, MBBS, also of the Mayo Clinic, in a statement. “The four individuals who experienced rebound represent only 0.8% of the group, and all of them recovered quickly without additional COVID-directed therapy.”

That’s certainly good news to read.

From the Rx coverage front, the Drug Channels blog tears apart a recent JAMA study concluding that the pricing of recently launched drugs has skyrocketed in recent years.

[T]he study’s headline conclusion is highly misleading. The authors obscure the real story with mathematical sleight-of-hand that misrepresents the underlying data and overlooks the true nature of today’s pharmaceutical innovations. 

Most notably, the authors discount the fact that the most expensive new drugs treat ultra-rare conditions affecting extraordinarily small patient populations. Their policy recommendations would therefore have a devastating impact on these patients and their hope for treatments and cures. 

As Nobel prize winner Ronald Coase observed: “If you torture the data long enough, it will confess to anything.”

And the Dr. Fein can back up his conclusion.

From general healthcare front, Kaiser Health News offers thought provoking articles about

The first article draws an important distinction between medical care and SDOH. Unfortunately, the second article reminds us that no good deed goes unpunished. If the government simply had relied on personal responsibility (outside of Medicaid), we would not find ourselves in this pickle.

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, HIPAA Privacy and Security Rules, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

A Covid-19 vaccine developed by Sanofi SA and GSK PLC to target the Beta strain of the virus produced a stronger antibody response against variants of Omicron when given as a booster compared with certain first-generation shots, two studies have found.

The results are the latest indication that tweaking vaccines can nudge antibody responses in the direction of new variants, possibly helping to shore up immunity as the virus mutates. The study results may also provide an opportunity for Sanofi and GSK, two vaccine giants that were late to develop Covid-19 immunizations, to play a role in providing booster shots.

What’s more, according to the Journal

A panel of advisers to the Food and Drug Administration is set to meet Tuesday [June 14] to consider whether use of Moderna Inc.’s Covid-19 vaccine should be expanded to include children ages 6 through 17.

The advisory committee is expected to vote Tuesday afternoon on whether the benefits of vaccinating children in this age group outweigh the risks. The FDA will consider the vote in making a final decision on whether to clear the vaccine for use in children 6 years and older.

An FDA authorization could come within days. It would open the use of Moderna’s vaccine to children for the first time in the U.S., and give anyone still intending to inoculate their children 6 years and older against Covid-19 a second option.

Moderna’s vaccine has been authorized for use in adults 18 years and older since late 2020, while use of the other leading Covid-19 vaccine, from Pfizer Inc. and BioNTech SE, was expanded to anyone 5 and older last year.

From the FTC investigation front, FierceHealthcare updates us on the recently launched FTC investigation of the six largest PBMs. In other FTC news, Healthcare Dive tells us

** UnitedHealth and LHC Group have been hit by a request for additional information on their acquisition from the Federal Trade Commission, as regulators take an increasingly active role in overseeing healthcare M&A.

** The second request extends the waiting period the FTC has to challenge the deal. UnitedHealth agreed to acquire home health and hospice provider LHC for $5.4 billion in March.

** https://www.healthcaredive.com/news/regulators-unitedhealth-lhc-request-merger/625343/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202022-06-13%20Healthcare%20Dive%20%5Bissue:42394%5D&utm_term=Healthcare%20DiveIn a filing with the SEC on Friday, the companies said they have been complying with regulators and will continue to do so.

Speaking of home health care, Home Health News discusses Aetna’s interest in the topic.

Aman Gill, Aetna’s director of product strategy and innovation, told Home Health Care News last month that a home health acquisition was “on the table” for the company. 

This past week, at HHCN’s VALUE event, Aetna CMO Dr. Kyu Rhee reiterated the company’s commitment to the home as a setting of care. He also explained how care delivery has changed over the course of the last few years.

“We’ve been committed to home health and virtual care during the pandemic,” Rhee said. “And in our Medicare program, we’ve delivered tens of thousands of healthy at-home visits as well. … So my challenge to us as we think about the opportunity we have now and the next stage of this pandemic is: Are we going to persist in those values and make sure that the system delivers on those values, that hopefully we’ve learned over the last couple of years?”

From the Rx coverage front, the Food and Drug Administration announced

the [agency approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year. Today’s action marks the first FDA approval of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

The drug initially was FDA-approved for the treatment of rheumatoid arthritis in 2018.

From the HIPAA Privacy Rule front, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), announced

issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth – PDF is no longer in effect. * * *

The Guidance on How the HIPAA Rules Permit Health Plans and Covered Health Care Providers to Use Remote Communication Technologies for Audio-Only Telehealth may be found at: https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-audio-telehealth/index.html.

Weekend update

David Ermer–Congress, COVID-19, Rx coverage, U.S. Healthcare–
Mount Rushmore

From the Capitol Hill front, the House of Representatives and the Senate will be in session this week for floor voting and Committee business.

Roll Call reports

A bipartisan group of senators announced an agreement Sunday on significant updates to the nation’s gun laws, and the Senate majority leader said it ​​would be put on the floor once legislative text is ready.

The agreement, announced by 10 Republicans and 10 Democratic caucus members, certainly will not go as far as many Democrats would have hoped, but the scale of the GOP support suggests it could get the all-important 60 votes to overcome the filibuster rule that kept derailing the last bipartisan attempt to change gun laws, in 2013.

The agreement, which is not yet in legislative language, is the product of discussions led by Sens. Christopher S. Murphy, D-Conn., and John Cornyn, R-Texas, in the wake of recent mass shootings, including at an elementary school in Uvalde, Texas.

“Our plan increases needed mental health resources, improves school safety and support for students, and helps ensure dangerous criminals and those who are adjudicated as mentally ill can’t purchase weapons,” the 20 senators said in a statement. “Most importantly, our plan saves lives while also protecting the constitutional rights of law-abiding Americans.”

From the Omicron and siblings front —

MedPage Today discusses the latest Omicron siblings — BA.4 and BA.5. “Generally, BA.4 and BA.5 variants cause mild disease but spread in large numbers potentially because, unlike the Wuhan strain, which settles in the lungs, these newer strains seem to attach to the more benign upper nasal passages.”

Bloomberg Prognosis answers a reader’s question about whether to get a fourth Covid booster now.

Moderna said just this week that a new version of its Covid vaccine led to a better antibody response against omicron compared with its current mRNA shot. It plans to submit data to the US Food and Drug Administration in the coming weeks and hopes the shot will be available as soon as late summer. That shot is what’s called a bivalent vaccine, meaning it contains mRNA coding for the spike protein of both the original strain of the virus and omicron. 

Pfizer should also have updated mRNA vaccines available as soon as the fall, says Monica Gandhi, an infectious disease expert at the University of California, San Francisco. The FDA will hold an advisory committee meeting later this month to address whether fall shots should be modified, and if so what strains they should include.

But while currently available boosters are less effective against omicron, Gandhi points out, they still do offer some protection. So, she says, that answer to whether to get boosted now depends on a few factors. 

”I would advise — depending on case rates in your area and your age— getting the fourth dose now,” she says. “And then deciding what to get in the fall.”

MedPage Today also explains why “the [Novovax Covid] technology is quite innovative and has potential to enhance protection against” the disease.

From the healthcare business front, the Wall Street Journal reports on a

A philanthropic organization founded by the ex-energy trader [John Arnold] and his wife Laura is providing financial backing to three lawsuits against giant hospital systems in Wisconsin, Connecticut and North Carolina, alleging the systems used their market power to squash competition and illegally inflate prices. The systems say the lawsuits from employers and consumers are baseless. * * *

The financing from Arnold Ventures is supporting the work of Fairmark Partners LLP, the law firm behind the lawsuits. Fairmark secured its funding from the philanthropy after filing its first lawsuit, one of the founders said. The firm’s founders say the backing is key to a targeted effort to reshape hospital markets through the courts, and that it received money from other philanthropies it declined to identify. 

While the FEHBlog is not a fan of litigation, this strikes him as a worthy effort.

From the medical research front —

  • Kaiser Health News summarizes recent drug research developments.
  • NPR Shots reports on efforts to connect human nerve systems to prosthetic devices.
  • Fierce Healthcare tells us

Researchers at CVS studied the relationship between total cost of care and the use of National Comprehensive Cancer Network (NCCN) guidelines to direct care and found savings among both breast cancer and colon cancer patients. The studies, released at the American Society of Clinical Oncology’s meeting earlier this month, build on a similar analysis among lung cancer patients.

In both studies, the researchers found that using NCCN guidelines drove significant declines in total cost of care.

“Evidence-based medicine does result in improvement in quality of life,” Shirisha Reddy, M.D., senior medical director at CVS Health and an author on both studies, told Fierce Healthcare. “There’s a lot of external data that supports that.”

The first study included 937 patients with colon cancer. Among Medicare beneficiaries, concordance with NCCN guidelines was linked to a 33% reduction in total cost per care per member per month. The results were less significant among commercially insured patients.

In the second study, the researchers retrospectively looked at 315 patients with breast cancer. They found total cost of care reductions for patients treated in ways consistent with NCCN across multiple insurance types, including 25% among fully insured commercial patients, 28% among self-insured commercial patients and 43% in Medicare.

This included notable decreases in administered chemotherapy spend as well as outpatient care between Jan. 1, 2019, and Dec. 31, 2020.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From our Nation’s capital, the New York Times reports,

White House officials said on Wednesday that they would have to repurpose federal Covid-19 funds meant for coronavirus tests and protective equipment in order to supply more antiviral pills and vaccines, after so far failing to persuade Congress to pass a new pandemic relief package.

Roughly $10 billion from Department of Health and Human Services funds will be rerouted, around half of it to purchase vaccines for Americans ahead of a possible fall or winter wave of virus cases, when an updated shot may be needed, according to one White House official. The other half will go mostly to purchasing 10 million courses of Paxlovid, the antiviral treatment made by Pfizer that has been shown to substantially reduce the severity of Covid-19 in high-risk people, the official said. Around $300 million will be spent on another kind of treatment, monoclonal antibodies.

Also from the Omnicron and siblings front, a friend of the FEHBlog, journalist Theresa Defino, points out

Today and tomorrow NIH’s Advisory Committee to the Director is holding its first of two annual meetings. Today Dr. Fauci gave a presentation on Covid and Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke, spoke on recovery from Covid.

The most interesting comments Dr. Fauci made begin on page 45. Dr. Koroshetz’s talk was about NIH’s efforts to understand long COVID. Lots of trials are going on. He also mentioned this website on Covid recovery which is worth a look. 

From the unusual viruses report, Becker’s Hospital Review brings us up to date on roughly 700 cases of acute hepatitis of unknown etiology infecting young children in 34 countries, including our own. “The U.S. has reported 274 probable hepatitis cases in 39 states and jurisdictions as of June 8, according to the CDC.”

From the maternal health front, the American Hospital Association informs us

The Health Resources and Services Administration has released a report evaluating the Rural Maternity and Obstetrics Management Strategies Program, which completed its first year last August. The program uses a network approach to coordinate and improve maternal health care from preconception to postpartum; telehealth services to increase access to care in rural areas; potential aggregation of low-volume rural obstetric services; and payment structures that promote financial sustainability for access to high-quality maternal care. The cohort includes networks in Missouri, New Mexico and Texas that provided prenatal, delivery and postpartum care to 3,101 rural mothers. Participants said hiring patient navigators emerged as an early success strategy. The networks also laid the groundwork for expanding telehealth.

From the Rx coverage front, STAT News offers an interesting article about the drug pricing reform debate ongoing in Congress using an AMA Journal report showing skyrocketing launch prices for newly approved drugs.

Health Payer Intelligence tells us that “AHIP has subscribed to the Institute for Clinical and Economic Review’s (ICER) cloud-based analytics platform, providing [its] health plan members with access to benchmark reports, cost-effectiveness data, and policy recommendations.” Good idea, AHIP.

From the federal employee benefits front, a financial planner discusses how divorce may affect FEHB and FEGLI benefits at the My Federal Retirement website.

From the HIPAA standard transactions front, the CMS National Standards Group has released an updated Compliance Review Program Findings report identifying the most common violations of those standard and operating rules from compliance reviews.